OCTRODE LEAD KIT, 60CM LENGTH 3186

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-31 for OCTRODE LEAD KIT, 60CM LENGTH 3186 manufactured by St. Jude Medical - Neuromodulation.

Event Text Entries

[185979716]
Date of event is estimated. During processing of this complaint, attempts were made to obtain complete event information. The results/method and conclusion codes along with investigation results will be provided in the final report. Patient Sequence No: 1, Text Type: N, H10

[185979717]
Device 4 of 4. Related manufacturer reference number: 1627487-2020-03501. Related manufacturer reference number: 1627487-2020-03502. Related manufacturer reference number: 1627487-2020-03503. It was reported the patient underwent explant of scs system for unknown reason on (b)(6) 2020. Further information revealed the patient was no longer using the system, but further details were unable to be obtained. Patient Sequence No: 1, Text Type: D, B5

[186235868]
Further information revealed that the patient needed an mri and a pacemaker, making explant of the scs system elective. As the explant was elective, it does not meet reportability criteria. Patient Sequence No: 1, Text Type: N, H10